Bsi bs en 60601 2 57 2011

MEDICAL ELECTRICAL EQUIPMENT – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic,

raising standards worldwide™

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BSI Standards Publication

Medical electrical equipment

Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for theraputic, diagnostic, monitoring and cosmetic/aesthetic use

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 30 June 2011

Amendments issued since publication Amd No Date Text affected

NORME EUROPÉENNE

CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members

Ref No EN 60601-2-57:2011 E

ICS 11.040.50; 11.040.60

English version

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic,

diagnostic, monitoring and cosmetic/aesthetic use

(IEC 60601-2-57:2011)

Appareils électromédicaux -

Partie 2-57: Exigences particulières pour

la sécurité de base et les performances

essentielles des appareils à source de

lumière non-laser prévus pour des

utilisations thérapeutiques, de diagnostic,

kosmetische/ästhetische Zwecke (IEC 60601-2-57:2011)

This European Standard was approved by CENELEC on 2011-03-07 CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member

This European Standard exists in three official versions (English, French, German) A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified

to the Central Secretariat has the same status as the official versions

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom

Foreword

The text of document 76/438/FDIS, future edition 1 of IEC 60601-2-57, prepared by IEC TC 76, Optical radiation safety and laser equipment, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-57 on 2011-03-07

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CEN and CENELEC shall not be held responsible for identifying any or all such patent rights

The following dates were fixed:

– latest date by which the EN has to be implemented

at national level by publication of an identical

national standard or by endorsement (dop) 2011-12-07

– latest date by which the national standards conflicting

with the EN have to be withdrawn (dow) 2014-03-07

This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of

EC Directive MDD (93/42/EEC) See Annex ZZ

In this standard, the following print types are used:

– Requirements and definitions: roman type

– Test specifications: italic type

– Informative material appearing outside of tables, such as notes, examples and references: in smaller type Normative text of tables is also in a smaller type

– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:

SMALL CAPITALS

In referring to the structure of this standard, the term

– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g Clause 7 includes subclauses 7.1, 7.2, etc.);

– “subclause” means a numbered subdivision of a clause (e.g 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7)

References to clauses within this standard are preceded by the term “Clause” followed by the clause number References to subclauses within this particular standard are by number only

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination

of the conditions is true

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2 For the purposes of this standard, the auxiliary verb:

− “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard;

− “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard;

− “may” is used to describe a permissible way to achieve compliance with a requirement or test

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA

Annexes ZA and ZZ have been added by CENELEC

The following referenced documents are indispensable for the application of this document For dated

references, only the edition cited applies For undated references, the latest edition of the referenced

document (including any amendments) applies

IEC 60947-3 - Low-voltage switchgear and controlgear -

Part 3: Switches, disconnectors, disconnectors and fuse-combination units

- -

Compliance with this standard provides one means of conformity with the specified essential

requirements of the Directive concerned

WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard

_

CONTENTS

INTRODUCTION 7

201.1 Scope, object and related standards 8

201.2 Normative references 10

201.3 Terms and definitions 10

201.4 General requirements 13

201.5 General requirements for testing ME EQUIPMENT 13

201.6 Classification of ME EQUIPMENT and ME SYSTEMS 13

201.7 ME EQUIPMENT identification, marking and documents 15

201.8 Protection against electrical HAZARDS from ME EQUIPMENT 19

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 20

201.10 Protection against unwanted and excessive radiation HAZARDS 20

201.11 Protection against excessive temperatures and other HAZARDS 21

201.12 Accuracy of controls and instruments and protection against hazardous outputs 21

201.13 HAZARDOUS SITUATIONS and fault conditions 22

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 23

201.15 Construction of ME EQUIPMENT 23

201.16 ME SYSTEMS 23

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 23

Annexes 23

Annex AA (informative) Particular guidance and rationale 24

Annex BB (informative) Exposure limit values 26

Annex CC (informative) Protective eyewear for LS EQUIPMENT 30

Annex DD (informative) Summary of MANUFACTURER’S requirements 31

Annex EE (informative) Symbols on marking 32

Bibliography 33

Index of defined terms used in this particular standard 34

Figure 201.101 – Example of explanatory label for a device with multiple HAZARD spectral regions 18

Figure 201.102 – Warning label – HAZARD symbol 19

Table 201.101 – EMISSION LIMITS for risk groups of LS EQUIPMENT 14

Table 201.102 – Risk group time base criteria for classification of LS EQUIPMENT 15

Table 201.103 – Applicable ANGLE OF ACCEPTANCE for the assessment of accessible emission from LS EQUIPMENT 15

Table 201.104 – Requirements for labelling of LS EQUIPMENT according to risk group classification 17

Table BB.1 – EXPOSURE LIMIT values for non-coherent OPTICAL RADIATION 26

Table BB.2 – S(λ) [dimensionless], 200 nm to 400 nm 28

Table BB.3 – B (λ), R (λ) [dimensionless], 300 nm to 1 400 nm 29

Table DD.1 – Summary of MANUFACTURER’S requirements 31 Table EE.1 – Symbols, references and descriptions 32

INTRODUCTION

This particular standard amends and supplements IEC 60601-1:2005 (third edition): Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance

The requirements of this particular standard should be taken as the minimum to comply with,

in order to achieve a reasonable level of safety and reliability during operation and application

of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

An asterisk (*) notes clauses for which there is rationale comment in Annex AA It is considered that knowledge of the reasons for these requirements will facilitate the proper application of this particular standard and be of use in any revision that may be necessitated

by changes in clinical practice or as a result of developments in technology

MEDICAL ELECTRICAL EQUIPMENT – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic,

diagnostic, monitoring and cosmetic/aesthetic use

201.1 Scope, object and related standards

Clause 1 of the general standard1) applies, except as follows:

photo-This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy

NOTE Safety requirements in this particular standard are intended to address only HAZARDS to the eye and skin; hazards to internal tissues are not included in its scope

LS EQUIPMENT may consist of a single or multiple sources of OPTICAL RADIATION, with or without power supply, or may be incorporated into a complex system that includes optical, electrical

or mechanical systems or sources of other radiation

NOTE Annexes AA to EE have been included for purposes of general guidance and to illustrate many typical cases However, the annexes should not be regarded as definitive or exhaustive

201.1.2 Object

Replacement:

The objects of this particular standard are:

– to establish optical radiation safety, basic safety and essential performance requirements for LS EQUIPMENT;

– to specify requirements for the MANUFACTURER to supply information and establish procedures so that proper precautions can be adopted;

– to provide warning to individuals of HAZARDS associated with accessible OPTICAL RADIATION

from LS EQUIPMENT through signs, labels and instructions;

– to reduce the possibility of injury by minimizing unnecessary accessible OPTICAL RADIATION;

to provide means of improved control of the HAZARDS related to OPTICAL RADIATION through protective features and to assist safe use of LS EQUIPMENT;

_

1) The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance

– to protect persons against other HAZARDS resulting from the operation and use of

A requirement of a particular standard takes priority over the general standard

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard Collateral standards are referred to by their document number

The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g 201.1 in this particular standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix

“20x” where x is the final digit(s) of the collateral standard document number (e.g 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.) The changes to the text of the general standard are specified by the use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard

"Addition" means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard

"Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard

Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101 However, due to the fact that definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this particular standard are numbered beginning from 201.3.201 Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc

Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc

The term "this standard" is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together

Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard

201.2 Normative references

NOTE Informative references are listed in the Bibliography on page 33

Clause 2 of the general standard applies, except as follows:

Addition:

IEC 60947-3, Low voltage switchgear and controlgear – Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units

IEC 62471, Photobiological safety of lamps and lamp systems

ISO 3864-2, Graphical symbols – Safety colours and safety signs – Part 2: Design principles for product safety labels

201.3 Terms and definitions

NOTE An index of defined terms used in this document is found beginning on page 34

For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, apply, except as follows:

plane angle within which a detector responds to OPTICAL RADIATION

NOTE 2 The ANGLE OF ACCEPTANCE is sometimes referred to as the field-of-view

SI Unit: radian (rad)

SI Unit: radian (rad)

201.3.209

LS EQUIPMENT OUTPUT

either radiant power or radiant energy emitted by the LS EQUIPMENT

201.3.210

OCULAR HAZARD DISTANCE ( OHD )

distance from an EMISSION APERTURE within which the projected radiant exposure or irradiance for a given EXPOSURE TIME equals the applicable EXPOSURE LIMIT value for the eye

time between the end of one PULSE and the onset of the following PULSE, measured at the

50 % trailing and leading edges respectively

SHORT WAVELENGTH BOUNDARY

wavelength at the 50 % point of the emission spectrum at its short wavelength edge

SI Unit: nm

201.3.220

SKIN HAZARD DISTANCE

distance from an EMISSION APERTURE within which the projected radiant exposure or irradiance for a given EXPOSURE TIME equals the applicable EXPOSURE LIMIT value for the skin

201.4 General requirements

Clause 4 of the general standard applies

201.5 General requirements for testing ME EQUIPMENT

Clause 5 of the general standard applies

201.6 Classification of ME EQUIPMENT and ME SYSTEMS

Clause 6 of the general standard applies, except as follows:

201.6.1 General

Addition:

201.6.1.101 *Classification responsibilities

The MANUFACTURER shall provide the classification of LS EQUIPMENT

The LS EQUIPMENT shall be classified on the basis of the emission of the accessible OPTICAL RADIATION over the full range of capability during operation at any time after manufacture and under every reasonably foreseeable single fault condition

NOTE Classification of LS EQUIPMENT provides the basis for the range of control measures which the USER should take in order to minimize risk of excessive exposure to OPTICAL RADIATION

201.6.1.102 *Classification rules

The classification is used to indicate the potential risk of adverse health effects

For the purpose of classification rules, the following ranking of the risk groups, in order of increasing risk at a distance of 200 mm from the EMISSION APERTURE, shall be used Assessment shall be made by the method specified in IEC 62471:

– Exempt Group – no photo-biological HAZARD;

– Risk Group 1 – low risk group; the risk is limited by normal behavioural limitations on exposure;

– Risk Group 2 – moderate risk group; the risk is limited by the aversion response to very bright light sources However, such reflex responses do not occur universally;

– Risk Group 3 – high risk group; LS EQUIPMENT that may pose a risk even for momentary or brief exposure

NOTE Risk Groups are described in IEC 62471

201.6.1.102.1 Classification of continuous operation LS EQUIPMENT

a) Exempt Risk Group

CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to the Exempt Risk Group if its accessible emission does not exceed the EMISSION LIMITS in any of the HAZARD spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102 and the

ANGLE OF ACCEPTANCE γ specified in Table 201.103

b) Risk Group 1

CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to Risk Group 1 if its accessible emission exceeds one or more EMISSION LIMITS for the Exempt Group as defined in Table 201.101 and does not exceed EMISSION LIMITS of Risk Group 1 in any of the HAZARD

spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102 and the ANGLE OF ACCEPTANCE γ specified in Table 201.103

c) Risk Group 2

CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to Risk Group 2 if its accessible emission exceeds one or more EMISSION LIMITS for Risk Group 1 as defined in Table 201.101 and does not exceed EMISSION LIMITS of Risk Group 2 in any of the HAZARD

spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102 and the ANGLE OF ACCEPTANCE γ specified in Table 201.103

d) Risk Group 3

CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to Risk Group 3 if its accessible emission exceeds one or more EMISSION LIMITS for Risk Group 2 as defined in Table 201.101

Table 201.101 – E MISSION LIMITS for risk groups of LS EQUIPMENT

H AZARD

Wavelength range

nm

Symbol

Emission limits

Units Exempt Group Risk Group 1 Risk Group 2

Actinic UV 180 – 400 Es 0,001 0,003 0,03 W⋅m 2

Blue light 300 – 700 LB 100 10 000 4 000 000 W⋅m 2 ⋅sr 1

Retinal thermal 380 – 1 400 LR 28 000/α N/A a 71 000/α W⋅m 2 ⋅sr 1

Retinal thermal, weak visual

stimulus 780 – 1 400 LIR 6 000/α N/A a N/A a W⋅m 2 ⋅sr 1

201.6.1.102.2 Classification of PULSED LS EQUIPMENT

For PULSED LS EQUIPMENT, classification criteria shall apply to the most restrictive of the requirements for a single PULSE, or any group of PULSEs within the time criteria of the applicable HAZARD region given in Table 201.102 EMISSION LIMITS for PULSED LS EQUIPMENT

shall be calculated according to IEC 62471

a) Exempt Risk Group

PULSED LS EQUIPMENT shall be assigned to the Exempt Risk Group if its accessible emission does not exceed EMISSION LIMITS in any of the HAZARD spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102 and ANGLE OF ACCEPTANCE γ specified in Table 201.103

b) Risk Group 1

PULSED LS EQUIPMENT shall be assigned to Risk Group 1 if its accessible emission exceeds one or more EMISSION LIMITS for the Exempt Group as defined in Table 201.101 and does not exceed the EMISSION LIMITS of Risk Group 1 in any of the HAZARD spectral regions of Table 201.101 when assessed for the time criteria of Table 202.102 and ANGLE OF ACCEPTANCE γ specified in Table 201.103

c) Risk Group 2

PULSED LS EQUIPMENT shall be assigned to Risk Group 2 if its accessible emission exceeds one or more EMISSION LIMITS for Risk Group 1 as defined in Table 201.101 and does not exceed the EMISSION LIMITS of Risk Group 2 in any of the HAZARD spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102 and the ANGLE OF ACCEPTANCE γ specified in Table 201.103

d) Risk Group 3

PULSED LS EQUIPMENT shall be assigned to Risk Group 3 if its accessible emission exceeds one or more EMISSION LIMITS for Risk Group 2 as defined in Table 201.101

Table 201.102 – Risk group time base criteria for classification of LS EQUIPMENT

H AZARD Wavelength range

Table 201.103 – Applicable ANGLE OF ACCEPTANCE for the assessment of accessible

emission from LS EQUIPMENT

H AZARD Wavelength range

nm

Angle of acceptance γ

rad

Exempt Risk Group Risk Group 1 Risk Group 2

Blue-light 300 – 700 0,11 0,011 0,0017 Retinal Thermal 380 – 1 400 0,011 N/A 0,0017 Retinal Thermal, weak visual

Corneal/Lens IR 780 – 3 000 1,4 1,4 1,4

201.7 ME EQUIPMENT identification, marking and documents

Clause 7 of the general standard applies, except as follows:

201.7.9 A CCOMPANYING DOCUMENTS

201.7.9.1 General

Addition:

MANUFACTURERS of LS EQUIPMENT shall provide instructions for proper operation, including clear warnings concerning precautions to avoid possible exposure to hazardous OPTICAL RADIATION

201.7.9.2 Instructions for use

201.7.9.2.13 Maintenance

Addition:

MANUFACTURERS of LS EQUIPMENT shall provide instructions for maintenance to be performed

by the USER, including warnings concerning precautions to avoid possible exposure to hazardous OPTICAL RADIATION

Additional subclauses:

201.7.9.2.101 Specific information for LS EQUIPMENT

201.7.9.2.101.1 Information on output

The MANUFACTURER of LS EQUIPMENT shall provide the following information for the USER:

– spectral irradiance or spectral radiant exposure for all intended configurations of

LS EQUIPMENT;

– maximum output of OPTICAL RADIATION for all intended configurations of LS EQUIPMENT, measured at the treatment area If the LS EQUIPMENT is designed for providing treatment in different treatment areas, these parameters shall be specified for each of the treatment areas;

– maximum variation of the output from the mean value across the treatment area for all intended configurations of the equipment;

– OCULAR HAZARD DISTANCE and/or SKIN HAZARD DISTANCE, when the LS EQUIPMENT is classified in excess of Risk Group 1

For PULSED LS EQUIPMENT, for all intended operational settings of the equipment, the

MANUFACTURER shall provide an additional statement of:

– PULSE DURATION of individual pulses;

– duration of a PULSE TRAIN;

– recommendations for training;

– legible reproductions (colour optional) of all required labels and HAZARD warnings affixed

to the LS EQUIPMENT;

– a clear indication of all locations of EMISSION APERTURES;

– a list of controls, adjustments and procedures for operation and maintenance by the USER, including the warning "Caution – Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure"; – a note, saying that LS EQUIPMENT should be protected against unauthorised use, for example by removal of the key from the key switch;

– a recommendation for eye and skin protection for the USER and for the PATIENT/client

NOTE The MANUFACTURER should provide a warning of risk of fire if the LS EQUIPMENT is used in the presence of flammable materials, solutions or gases, or in an oxygen enriched environment Some materials, e.g darkly coloured clothing or cotton wool, when saturated with oxygen, may be ignited by the high temperatures produced in

NORMAL USE of the LS EQUIPMENT

NOTE Wording that conveys an equivalent meaning is acceptable

Table 201.104 – Requirements for labelling of LS EQUIPMENT

according to risk group classification

Actinic UV Not required

WARNING

UV emitted from this device may be hazardous Avoid eye or skin exposure

Near UV Not required

Blue-light Not required Not required

CAUTION The light emitted may be harmful to the eyes

Do not stare at the light source

WARNING The light emitted may result in eye injury

Do not look at the light source

Retinal

Thermal Not required Not applicable

CAUTION The light emitted may be harmful to the eyes

Do not stare at the light source

Avoid eye exposure